Rotaqor 10mg Film Coated Tablets

国: マレーシア

言語: 英語

ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有効成分:

ATORVASTATIN CALCIUM

から入手可能:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN（国際名）:

ATORVASTATIN CALCIUM

パッケージ内のユニット:

30Tablet Tablets

製:

LEK PHARMACEUTICALS D.D.

情報リーフレット

ROTAQOR
®
FILM-COATED
TABLETS
Atorvastatin (10mg, 20mg)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
WHAT IS IN THIS LEAFLET
1.
What is Rotaqor used for
2.
How Rotaqor works
3.
Before you use Rotaqor
4.
How to use Rotaqor
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Rotaqor
8.
Product description
9.
Manufacturer & Product
Registration Holder
10.
Date of revision
WHAT IS ROTAQOR USED FOR
You have been prescribed Rotaqor
because either:
(a)
You have a high cholesterol
level. This means you are at risk of
getting a heart attack or stroke.
You have been advised to take a
statin, because changing your diet and
taking more exercise were not enough
to correct your cholesterol levels. You
should continue with your
cholesterol-lowering diet and exercise
while you are taking Rotaqor.
Or
(b)
You have other factors that
increase your risk of getting a heart
attack, stroke or related health
problems.
HOW ROTAQOR WORKS
Rotaqor belongs to a group of
medicines called statins.
There are different types of
cholesterol found in the blood,
including – ‘bad’ cholesterol (LDL-
C) and ‘good’ cholesterol (HDL-C).
•
Rotaqor can reduce the ‘bad’
cholesterol and increase the
‘good’ cholesterol.
•
It works by helping to block
your body’s production of ‘bad’
cholesterol in the liver. It also
improves your body’s ability to
remove it from your blood.
For most people, high cholesterol
does not affect the way they feel
because it does not produce any
symptoms. However, if it is left
untreated, fatty deposits can build up
in the walls of your blood vessels
causing them to narrow.
Sometimes, these narrowed blood
vessels can get blocked which can
cut off the blood supply to the heart
or brain leading to a heart attack or a
stroke. By lowering your cholesterol
levels, you can reduce your risk of
getting a heart attack, a stroke or
related health problems
BEFORE YOU USE ROTAQOR
-
_When you must not use it _
•
If you are allergic (hypersensitive)
to atorvastatin, or to any of the
ingred

製品の特徴

1.
NAME OF THE MEDICINAL PRODUCT
Rotaqor 10 mg Film-coated Tablets
Rotaqor 20 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg film-coated tablet contains 10 mg of atorvastatin in the
form of calcium salt.
Each 20 mg film-coated tablet contains 20 mg of atorvastatin in the
form of calcium salt.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_Appearance: _
10 mg tablets are white to almost white, round, biconvex film-coated
tablets, debossed with “HLA 10” on
one side.
20 mg tablets are light yellow, round, biconvex film-coated tablets,
debossed with “HLA 20” on one side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Atorvastatin is indicated as an adjunct to diet for the treatment of
patients with elevated total cholesterol,
LDL-cholesterol, apolipoprotein B, and triglycerides and to increase
HDL-cholesterol in patients with
primary hypercholesterolemia (heterozygous familial and non-familial
hypercholesterolemia), combined
(mixed) hyperlipidemia (_Fredrickson _Types IIa and IIb), elevated
serum triglyceride levels (_Fredrickson _
Type IV), and for patients with dysbetalipoproteinemia (_Fredrickson_
Type III) who do not respond
adequately to diet.
Atorvastatin is also indicated for the reduction of total cholesterol
and LDL-cholesterol in patients with
homozygous familial hypercholesterolemia when response to diet and
other non-pharmacological
measures are inadequate.
_ _
_Prevention of Cardiovascular Disease _
In adult patients without clinically evident coronary heart disease,
but with multiple risk factors for
coronary heart disease such as age, smoking, hypertension, low HDL-C,
or a family history of early
coronary heart disease, atorvastatin is indicated to:
•
Reduce the risk of myocardial infarction
•
Reduce the risk of stroke
•
Reduce the risk for revascularization procedures and angina
In patients with type 2 diabetes, and without clinically evident
coronary heart disease, but with multiple
risk factors for coronar